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510(k) K080532

BENACEL, MODELS C-001, C-002 AND C-005 by Unicare Biomedical, Inc. — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2008
Date Received
February 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

Other clearances by Unicare Biomedical, Inc.

  • K151344 — Cytoflex Tefguard Ti-Enforced Membrane (November 19, 2015)
  • K092567 — MODIFICATION TO UNIGRAFT (November 25, 2009)
  • K090612 — BENACEL (July 24, 2009)
  • K090083 — CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 (March 23, 2009)
  • K021511 — CYTOFLEX MESH (August 6, 2002)
  • K020720 — OSSIFORM (May 7, 2002)
  • K012144 — CYTOFLEX (October 1, 2001)
  • K003457 — UNIGRAFT (January 9, 2001)
  • K993784 — UNIGRAFT (January 27, 2000)
  • K982699 — UNIGRAFE (October 20, 1998)

Other clearances for product code QSY

  • K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x (February 26, 2026)
  • K250319 — MFUSE (MS001) (December 15, 2025)
  • K253609 — TRAUMAGEL® 2.0 Hemostatic Gel (December 12, 2025)
  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (May 22, 2024)
  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K213413 — Hemostatic Dressing (September 1, 2023)